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Can a new formulation of Botulinum Toxin Type A improve its efficiency over the wrinkles?

Condition category

Not Applicable

Date applied

03/07/2017

Date assigned

10/07/2017

Last edited

10/07/2017

Prospective/Retrospective

Prospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsBotulinum toxin injections, also known as Botox or Dysport, are treatments that are injected to relax muscles. This is usually injected in to the face to improve the look of wrinkles. The botulinum toxin needs to be mixed with a saline to be reconstituted (restoring something dried by adding water or saline (salt water)). This can be done with different types of saline solutions, including sodium chloride or zinc gluconate. The aim of this study is to compare the effect of botulinum toxin treatments diluted with different compounds to see if they are effective.

Who can participate?Females aged 50 and older who have not received botulinum toxin injections for the last six months.

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group receive the treatment that is diluted with sodium chloride. Participants receive the treatment that is diluted with zinc gluconate. Participants receive a range from 8 to 25 units in their forehead. Participants are followed up two, four and 14 weeks after being treated to assess their wrinkles and quality of life.

What are the possible benefits and risks of participating?Participants may benefit from improvements in the wrinkles. There are risks of scratches, asymmetry, pain (at application), edema (swelling), ineffectiveness and ecchymosis.

Where is the study run from? Pontifical Catholic University of Rio Grande do Sul (Brazil)

When is the study starting and how long is it expected to run for? March 2014 to February 2018

Who is funding the study?Investigator initiated and funded (Brazil)

Who is the main contact?Dr Leonardo Ferreiraleonardoferreira@doctor.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

Null hypothesis:The effect of injecting the diluted botulinum toxin in 0.9% sodium chloride physiological solution has the same duration as the injection of botulinum toxin diluted in 0.02% zinc gluconate in the frontal muscle.

Hypothesis:The effect of injection of botulinum toxin diluted in 0.02% zinc gluconate has a longer duration than the injection of botulinum toxin diluted in saline solution only 0.9% sodium chloride in the frontal muscle.

Ethics approval

Research Ethics Committee of PUCRS, 09/12/2014, ref: 903.330

Study design

Prospective double-blind randomised longitudinal case/control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

The sample consisted of 48 female participants, over 50 years of age and divided into two groups. The participants were submitted to botulinum toxin application in the upper third of the face, specifically in the frontal muscle, and in 24 participants the dilution of Botulinum Toxin was with 0.02% Zinc Gluconate Solution (Case Group) and 24 participants with dilution Of Botulinum Toxin in 0.9% Physiological Solution (Control Group).

Intervention

Participants are randomly allocated to either the control of the case group.

All participants receive doses ranging from 8 to 25 units in the frontal muscle, according to recommendations of application in this region.

Participants in the control group receive a toxin diluted in 0.9% sodium chloride in each spot.

Participants in the case group receive the treatment toxin diluted in 0.02% zinc gluconate.

Participants receive the treatment once and then receive follow up on week two, four and 14 to assess their wrinkles and quality of life.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Wrinkle evaluation (on movement and at rest) is measured using the Merz Aesthetics scale at baseline, weeks two, four and 142. Quality of life is measured using the WHO Quality of Life score at baseline and week 14

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

02/03/2014

Overall trial end date

07/02/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All female participants2. 50 years of age or older3. Agreed to the study and signed the informed consent form4. No history of chronic gastrointestinal disease (diarrhea, inflammatory bowel disease or celiac disease) with frontal wrinkles5. Muscle contraction (dynamic)6. At least 6 months without receiving botulinum toxin application for any indication7. Participants who were never submitted to this treatment

Participant type

Other

Age group

Mixed

Gender

Female

Target number of participants

The sample consisted of 48 female participants, over 50 years of age and divided into two groups.

Participant exclusion criteria

1. Individuals of the male gender2. Female subjects under 50 years of age3. Did not agree to the study and did not sign the informed consent form4. History of chronic gastrointestinal disease (diarrhea, inflammatory bowel disease, or Celiac disease)5. Diabetes mellitus6. Lack of wrinkles to muscle contraction (dynamic or static)7. Underwent botulinum toxin treatment for less than 6 months for any indication were not included in the study